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OpenTrials
Completed

NCT Number: NCT02533440

Efficacy of EXPAREL in Comparison to Standard of Care for the Treatment of Post Operative Dental Implant Pain

This study is researching managing postsurgical pain by injecting both short-acting local anesthetics and EXPAREL® at the time of surgery and reviewing if it could reduce or eliminate the need for postsurgical opioids and improve clinical outcomes following the FAST dental implant surgery procedure. This approach is being compared to the current standard of care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ClearChoice Dental Implants, Atlanta, Georgia, United States

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About this study

Postsurgical pain following the Full Arch Surgical Therapy (FAST) dental implant surgery procedure is commonly managed with a variety of interventions, including local infiltration with short-acting local anesthetics during surgery and the use of postsurgical opioid and non-opioid analgesics. Although this approach to managing postsurgical pain is considered the current standard of care, its reliance on opioid analgesics to provide analgesia beyond the duration of short-acting local anesthetics exposes patients to opioid-related adverse events (ORAEs) that may delay their recovery and have other deleterious clinical consequences. The primary objective of this study is to determine the efficacy and safety of local infiltration of EXPAREL for the FAST dental implant surgery procedure compared to standard of care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older;
  • Ability to speak, read, and write in English;
  • Ability to communicate via telephone;
  • Scheduled to undergo FAST dental implant surgery procedure at a study center within the next 30 days for both maxillary and mandibular repair with at least 4 upper and 4 lower teeth to be extracted;
  • Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion criteria

  • Daily opioid consumption for more than 30 days prior to surgery;
  • Any opioid consumption within 3 days prior to surgery.
  • Prior treatment for alcohol, recreational drug, or opioid abuse.
  • Hypersensitivity or allergy to local anesthetics, non steroidal anti-inflammatory drugs, or opioids;
  • Breastfeeding, pregnant, or contemplating pregnancy prior to surgery.

Treatment and study plan

EXPAREL and Local Anesthetics

Procedure

Patients will receive EXPAREL and local anesthetics, as well as opioid and non-opioid analgesics prescription, (only use if needed, for post surgical pain)

Oral Opioid and Local Anesthetics

Procedure

Patients will receive local anesthetics, as well as oral opioid or non-opioid analgesics, (only use if needed, for post surgical pain)

Primary outcomes

  1. Postsurgical Pain Severity

    Time frame: 7 days

Secondary outcomes

  1. Food ingesting tolerance

    Time frame: 7 days

    Ability to ingest different foods

  2. Analgesic medication use

    Time frame: 7 days

    Analgesic medication use

  3. Patient Satisfaction

    Time frame: 7 days

    Patient Satisfaction with pain control

  4. Incidence of ORAEs and other adverse events (AEs)

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Bellaire Facial Surgery Center

Other

Registry information

Official study title

A Prospective, Randomized, Open-Label Study Comparing Postsurgical Analgesia Using EXPAREL® To Standard Of Care For The Full Arch Surgical Therapy (FAST) Dental Implant Surgery Procedure

Acronym: FAST

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2015
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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